Recall Z-3285-2011 ยท FRN Pump, Infusion
Hospira Inc.
Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software The Plum A+3 is a dual-line triple channel volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternat
| Date | Sep 29, 2011 (initiated Sep 16, 2011) |
| Status | Terminated |
| Reason | Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened, and if the clinician has not engaged the clamp prior to opening the cassette door, unrestricted flow may occur. |
| Root cause | Nonconforming Material/Component |
| Action | Hospira, Inc. sent an "URGENT DEVICE RECALL" letter dated September 16, 2011 to all affected customers. The letter describes the product, problem and actions to be taken by the customers. The letter instructs customers on how to prevent occurrences of continuous recycling/rebooting during start-up. A reply form was attached to the letter for customers to complete and return via fax to 1-888-345-5358. Contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, for technical assistance or information regarding this notice. |
| Quantity | 24,992 pumps |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico and the U. S. Virgin Islands and countries of Argentina, Australia, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Ital |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031185 | ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE Abbott Laboratories, Apr 30, 2003 |
| K042081 | PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Hospira, Inc., Aug 24, 2004 |
| K052052 | HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5 Hospira, Inc., Aug 24, 2005 |